FDA.reportPublic FDA data

mirvetuximab soravtansine-gynx 100 MG in 20 ML Injection

RxCUI
2621553
RxNorm name
mirvetuximab soravtansine-gynx 100 MG in 20 ML Injection
Display name
mirvetuximab soravtansine-gynx 100 MG in 20 ML Injection
Full name
mirvetuximab soravtansine-gynx 100 MG in 20 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761310Elaheremirvetuximab soravtansine-gynx351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAHEREMIRVETUXIMAB SORAVTANSINEImmunoGen, Inc.00c424b5-6ccd-48ab-9e88-1986451120e22025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2621553

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
00c424b5-6ccd-48ab-9e88-1986451120e2mirvetuximab soravtansine-gynx 100 MG in 20 ML InjectionPSN14These highlights do not include all the information needed to use ELAHERE safely and effectively. See full prescribing information for ELAHERE. ELAHERE ® (mirvetuximab soravtansine-gynx) injection, for intravenous use . Initial U.S. Approval: 202220250714
00c424b5-6ccd-48ab-9e88-1986451120e2mirvetuximab soravtansine-gynx 100 MG per 20 ML InjectionSY14These highlights do not include all the information needed to use ELAHERE safely and effectively. See full prescribing information for ELAHERE. ELAHERE ® (mirvetuximab soravtansine-gynx) injection, for intravenous use . Initial U.S. Approval: 202220250714
00c424b5-6ccd-48ab-9e88-1986451120e220 ML mirvetuximab soravtansine-gynx 5 MG/ML InjectionSCD14These highlights do not include all the information needed to use ELAHERE safely and effectively. See full prescribing information for ELAHERE. ELAHERE ® (mirvetuximab soravtansine-gynx) injection, for intravenous use . Initial U.S. Approval: 202220250714
00c424b5-6ccd-48ab-9e88-1986451120e2mirvetuximab soravtansine-gynx 5 MG/ML per 20 ML InjectionSY14These highlights do not include all the information needed to use ELAHERE safely and effectively. See full prescribing information for ELAHERE. ELAHERE ® (mirvetuximab soravtansine-gynx) injection, for intravenous use . Initial U.S. Approval: 202220250714